Applying for the "Opportunities for Collaborative Research at the NIH Clinical Center (U01)" - Frequently Asked Questions
These frequently asked questions (FAQs) are designed to assist investigators in learning more about establishing partnerships with NIH intramural investigators and accessing special NIH research resources. The FAQs provide general information about potentially available resources and partnerships, applying for access to research resources and logistics of utilizing resources and/or implementing a partnership. These FAQs are illustrative of general concepts only; sometimes the answer to a question may differ due to the situation. Each collaboration with NIH will be controlled by its corresponding written and executed agreement.
If you need more information, please contact ClinicalCtrPartner@mail.nih.gov.
Eligibility to Apply for the U01 Funding Opportunity
- May the extramural partner be a U.S. owned domestic for-profit organization, small business or otherwise?
- Are there any restrictions on federal agency participation, such as DARPA or HHS?
- Can an intramural investigator be listed as a PD/PI on a U01 grant application? The announcement encourages Multi-PI applications, but I thought intramural investigators could not be PIs on a NIH grant application.
- Can a project have two extramural PIs and one PI from the NIH intramural program? In other words, can the project have three PIs?
- Are foreign institutions and components eligible to apply?
- Must I be an intramural investigator an IC participating in the U01 funding opportunity to apply?
- Are sub-contract sites allowed separate from the multiple PI plan?
X02 Pre-application to Apply to the U01 Funding Opportunity
- What is the difference between the U01 Funding Opportunity Announcement (FOA) and the X02 FOA?
- Do I have to submit an X02 pre-application in order to submit a U01 application?
- Are the applications for the X02 and U01 different?
- I see that no awards will be made under the X02 announcement. What will the review of my X02 pre-application determine?
- Are there ways to get letters of support from the Clinical Center and the NIH intramural program if I missed the X02 deadline?
Building a Budget for the U01 Funding Opportunity
- How will the project budget be structured?
- How are Clinical Center costs determined, and what should I submit to document the costs in the application?
- How are intramural investigator costs determined, and what should I submit to document the costs in the application?
- How are indirect costs allocated for intramural and extramural investigators?
- Should patient travel to the Clinical Center be included in the extramural budget?
- Should we include the cost of a nurse coordinator at the Clinical Center in the intramural investigator's budget or in the Clinical Center budget?
- Since the Clinical Center is an entity receiving a subaward, should we expect a signed consortium agreement from the Clinical Center?
Applying for the U01 Funding Opportunity
- What is the difference between the Collaboration Plan and the Multiple PD/PI Leadership Plan, and are both plans required? What information should be included in each?
- Are other attachments allowed as part of the application?
- I am an investigator and am interested in applying as a principal investigator for the U01. If awarded, would the grant be counted as an extramural NIH award for me such that I would lose New Investigator status if I were to apply for an R01 as an extramural NIH investigator in the future?
- Is this PAR eligible for late submission?
- The study I would like to propose in response to this opportunity will only require sending samples taken from patients to NIH for further analysis. Patients will not be going to the Clinical Center for further management. Will this type of study qualify for this opportunity?
- Who is the best person to contact with respect to a project idea for this FOA?
- Is it necessary to have an FDA approved IND at the time of application?
- At the time of the submission deadline, does a clinical protocol need to be IRB approved? If not, at what level of development should the clinical protocol be at the time of submission of the application?
Renewals and Resubmissions
- What kind of application should I submit if my previous U01 application was unsuccessful?
- What kind of application should I submit if I received a U01 award that will be ending soon?
- Would I be able to submit an application after the due date?
- Are there other application requirements that I should heed?
Eligibility to Apply for the U01 Opportunity
The eligibility criteria include for-profit organizations, which would include small businesses. This is not a Small Business Innovation Research (SBIR) solicitation. The standard conditions of a U01 application apply to all applicants. Detailed information may be found in the NIH Grants Policy Statement: (http://grants.nih.gov/grants/policy/nihgps/HTML5/introduction.htm).
As described in the Funding Opportunity Announcement (FOA) "eligible agencies of the federal government" may apply.
Can an intramural investigator be listed as a PD/PI on a U01 grant application? The specific announcement (PAR-18-951) encourages Multi-PI applications, but I thought intramural investigators could not be PIs on a NIH grant application.
Yes, an intramural investigator may be listed as a PD/PI on a U01 grant application. An extramural investigator will be responsible for submitting the application and will be the contact PI.
Certainly. The application comes from the applicant institution, and that organization submits the application on behalf of the PI(s). The extramural PIs would have to meet the requirements of their respective institution(s).
There is no limit to the number of PIs, but the more PIs the more complex your plan becomes. There can be more than one intramural PI as well.
Yes, foreign institutions and components are eligible to apply. Please refer to: NOT-LM-14-004
Each IC determines which project(s) they will support based on their respective institute priorities. Some participating ICs may require that the intramural investigator, who is listed as the co-investigator on the application, be employed by that IC. Intramural investigators who have projects that may better align with another participating IC's scientific mission should contact the grants management staff listed in Section VII. Agency Contacts of the funding opportunity announcement to inquire about the IC's requirement on supporting intramural investigators not employed by that IC.
As long as the project has the required collaboration – one intramural investigator and one extramural investigator – then yes, a sub-contract would be allowed.
X02 Pre-application to Apply to the U01 Funding Opportunity
The X02 is a pre-application that serves as the recommended first step in submitting a U01 application. The X02 announcement will not result in an award, but will enable NIH staff to provide preliminary feedback about the ability of the NIH Clinical Center to support the work proposed and the relevance of the project to the research mission of the appropriate participating NIH Institute. In contrast, the U01 announcement is similar to other NIH announcements inviting researcher-initiated projects and may result in awards of up to $500,000/year in direct costs. The X02 pre-application requires less information than the full U01 application.
No. However, individuals interested in applying to the U01 funding opportunity are strongly encouraged to apply to the X02 pre-application, in order to reduce the burden on applicants should their research plan not be feasible to be conducted utilizing the resources of the NIH Clinical Center, or not relevant to the research missions of any of the participating NIH institutes. In addition, the submission of an X02 pre-application will facilitate the provision of letters of support from the Clinical Center Chief Scientific Officer and the relevant institute, which are required for a complete U01 application. Information provided in the X02 pre-application will also help to identify the relevant NIH Clinical Center costs, and thus facilitate preparation of the budget section for the U01 application. If you choose not to submit an X02 application, you must submit the required information through a letter of intent, as discussed below.
Yes, they are different. The X02 pre-application requires fewer application materials than the full U01 application. The X02 pre-application does not request budget information or appendix materials, and the Research Strategy section is limited to 6 pages. The Research Strategy for the X02 pre-application should be written in light of the specific review criteria listed in Section V of the X02 FOA, and should provide detailed information about the Clinical Center resources that will be used and the relevance of the project to the research mission of the appropriate participating NIH Institute. In contrast, more pages are allowed for the U01 Research Strategy, so that the U01 application may provide the level of detail normally expected for scientific peer review using the 5 standard review criteria and the additional review criteria and considerations for investigator-initiated research projects. Please read the instructions in both announcements for full details.
Although no awards will be made under the X02 FOA, investigators whose X02 pre-applications are meritorious, can be supported by the resources of the NIH Clinical Center, and align with the research missions of the participating NIH Institutes, will be notified of the opportunity to submit a U01 application. They will also receive the two letters of support from the Clinical Center and the appropriate NIH Institute at that time. These letters are required for submission of a complete U01 application as detailed in Section IV. Application and Submission Information of the U01. Letters of support can also be requested through the submission of a letter of intent, as discussed below.
Yes, view this page: http://www.cc.nih.gov/translational-research-resources/U01/letters-of-support.html for instructions on obtaining letters of support without the submission of an X02.
Building a Budget for the U01 Funding Opportunity
General budget instructions can be found in the Funding Opportunity Announcement in Section IV. Application and Submission Information. The project budget should not exceed $500,000 a year in direct costs, for a period of no more than four years. Applicants may request a fifth year if the first year is for planning and regulatory approvals. The budget should reflect this reduced activity for year 1. Funds should support the project costs of the extramural principal investigator, the intramural principal investigator / co-investigator, and the Clinical Center.
The Clinical Center and the intramural investigator costs associated with the research project will not be paid to the grantee, but instead will be provided directly by the awarding NIH Institute/Center to the Clinical Center and the intramural investigator, respectively.
|How to determine the costs||Materials to submit in the grant application, and where|
New for this FOA, the only NIH Clinical Center costs which may be included in the budget section of the application are the cost of drugs that are the subject of the study (standard of care drugs will be free). It is recommended that, when possible, investigators work with pharmaceutical partners to minimize the cost of the study drugs.
The extramural applicant will work with the intramural investigator to complete the Budget Template . The Budget Template contains instructions for completion and cost building tools for the study drugs.
The intramural investigator will send the completed Budget Template to the Clinical Center team at ClinicalCtrPartner@mail.nih.gov. The Clinical Center team will work with the intramural investigator to determine accurate Clinical Center costs based on the completed template.
Applicants should allow sufficient time to identify and calculate costs and receive confirmation from the Clinical Center team that costs are accurate.
Enter the Clinical Center costs as a "subaward" budget in the budget section of the application, using "NIH Clinical Center Costs" as the descriptor and attach appropriate justification (including the final Budget Template) and documentation including any spreadsheets as appropriate
Be sure to list the key personnel and their percent-effort (or "calendar months") on the project. Even though award funds cannot be used to pay the salaries of intramural government employees, you should still list the name(s) and their time on the project and then indicate "0" dollars. If the intramural partner plans to hire temporary personnel on contract, the salary costs as well as level of effort for those individuals should be detailed in the budget.
Please see Section 4.8 of the SF424 application instructions.
The intramural investigator is responsible for his or her intramural budget.
In general, the budget request will be limited to the incremental costs required for carrying out the proposed work if those costs can be specifically identified with the project. These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses.
Restrictions: Budget requests from federal agencies, including the NIH intramural program, may not include any salary and related fringe benefits for career, career conditional or other federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative costs).
Enter the Intramural Investigator costs as a "subaward" budget section of the application and attach appropriate justification as appropriate.
Be sure to list the key personnel and their percent-effort (or "calendar months") on the project. Even though award funds cannot be used to pay the salaries of intramural government employees, you should still list the name(s) and their time on the project and then indicate "0" dollars. If temporary personnel are to be hired on contract, the salary costs as well as level of effort for those individuals should be detailed in the budget.
Please see Section 4.8 of the SF424 application instructions.
The extramural institution is provided indirect costs in accordance with their indirect cost (F&A) rate at time of award. For the NIH portion of the project, there's no allocation of indirect costs.
Patient travel costs may be included in either the extramural or intramural budgets. Patient travel should not be included in the Clinical Center budget.
Any contract nurse hired specifically to work on the project should be included in the intramural investigator’s budget.
No, the Clinical Center will not typically provide a signed consortium agreement. However, if your institution requires an agreement to document the partnership, we can accommodate such a request.
Applying for the U01 Funding Opportunity
All applications submitted in response to the announcement must include a Collaboration Plan. A Leadership Plan is required for any application submitted using the Multiple PD/PI option. Although there will likely be some overlap or redundancy, both plans are required if the Multiple PD/PI option is used.
|Collaboration Plan||Multiple PD/PI Leadership Plan|
The required Collaboration Plan should describe how the proposed collaboration will be maintained throughout the duration of the award. The Collaboration Plan should focus on how the science will move forward; it should be prepared to align with the review criterion of Approach, which includes the following questions:
The following areas should be addressed in the Collaboration Plan:
The Collaboration Plan should be included as an attachment to the SF424 (R&R) Research and Related Other Project Information component under "Other Attachments". The filename "Collaboration Plan.pdf" should be used and will be reflected in the final image bookmarking for easy access by reviewers. The Collaboration Plan is NOT included in the page limit of the Research Strategy.
The Multiple PD/PI Leadership Plan should address the following administrative processes and PI responsibilities:
The Multiple PD/PI Leadership Plan should be included as an attachment to the SF424 (R&R) Research and Related Other Project Information component under "Other Research Plan Sections".
Examples of leadership plans are available on the Multiple PI website at http://grants.nih.gov/grants/multi_pi/index.htm.
Yes. You should include "other attachments" with your application as applicable. Please refer to the Application section of the FOA for specific details regarding "other attachments." https://grants.nih.gov/grants/guide/pa-files/PAR-18-951.html#_Section_VI._Award
I am an investigator and am interested in applying as a principal investigator for the U01. If awarded, would the grant be counted as an extramural NIH award for me such that I would lose New Investigator status if I were to apply for an R01 as an extramural NIH investigator in the future?
Yes, if you are serving as a PI (either intramural or extramural) on a Multiple PD/PI application that is selected for an award, you will lose your New Investigator (NI) status. However, if you apply as a co-investigator, your NIH status would be preserved (see: http://grants.nih.gov/grants/multi_pi/faq.htm). Additional information about New Investigators and Early Stage Investigators may be found at http://grants.nih.gov/grants/new_investigators/.
The late submission and continuous submission policies do not apply to this FOA (PAR-18-951). The alternative submission and review process is limited to NIH R01, R21, and R34 applications (including those that are AIDS-related) that would normally be received on standard submission dates (http://grants1.nih.gov/grants/funding/submissionschedule.htm). Continuous submission is not available for applications submitted for special dates (RFAs, some PARs) or other activity codes.
The study I would like to propose in response to this opportunity will only require sending samples taken from patients to NIH for further analysis. Patients will not be going to the Clinical Center for further management. Will this type of study qualify for this opportunity?
Yes, one of the requirements is that some work be done at the Clinical Center, but work is not limited to patient treatment at the Clinical Center. The project you described is not excluded from consideration, provided there is collaboration. Along with some work at the Clinical Center, key components will be collaborations and novel work to meet this FOA's intent. However, projects that take only minimal advantage of Clinical Center resources, such as projects only utilizing banked samples or data, will not be considered for funding.
The scientific/research contacts at the relevant institutes are listed in the FOA. These individuals would be your first point of contact. They can discuss the institute's research interests and help shepherd your request, identifying other contacts as needed.
At the time of the submission deadline, does a clinical protocol need to be IRB approved? If not, at what level of development should the clinical protocol be at the time of submission of the application?
IRB approval is one of the "just-in-time" requirements. IRB approval is not needed to submit an application, but would be needed in order to receive an award. Depending on where the clinical study was done – at the extramural institution and/or at the Clinical Center – there may potentially need to be more than one IRB review.
Renewals and Resubmissions
If your previous U01 application was a new application (-01), then the next U01 can be a resubmission (-01A1) and you will be able to include a 1-page introduction to summarize any changes made in response to the previous review. Alternatively, you may submit your next application as a new (-01) application, but then you would not be able to include the 1-page introduction. A resubmission must arrive within the 37-month window after the initial submission that it follows; after that, the only option is a new application. Both new and resubmission applications would be due on the same Application Due Date.
If your previous U01 application was a resubmission (-01A1), then your next U01 application would have to be a new application because second resubmissions ("A2s") are not allowed. Under the new resubmission policy, the subsequent "new" application need not demonstrate substantial changes in scientific direction compared to previously reviewed submissions. Any subsequent application submitted as new must not contain elements of a resubmission, including an Introduction or responses to the previous review. See NOT-DO-14-074 for more details.
In either case, applicants are strongly encouraged to submit an X02 pre-application under the companion Funding Opportunity Announcement PAR-18-950.
If you wish to seek continued U01 support for your research, you may submit either a renewal or a new application. A renewal application would be appropriate if you have made progress and accomplished most or all of your Specific Aims, and if you plan a logical continuation of your research project. A new application would be more appropriate if you plan to go in a new direction or expand the scope of the research. Both new and renewal applications would be due on the same application due date.
When deciding whether to submit a new or renewal application, it's a good idea to contact your program officer for advice. In addition, applicants are strongly encouraged to submit an X02 pre-application under the companion Funding Opportunity Announcement.
There are two policies that address submission after the application due date:
Continuous Submission procedures were initiated to recognize outstanding review and advisory service by members of the scientific community, and to minimize disincentives to such service. This alternative submission and review process is limited to NIH R01, R21, and R34 applications (including those that are AIDS-related) that would normally be received on standard submission dates. Continuous submission is NOT available for applications submitted for special dates (RFAs, some PARs) or other activity codes. Therefore, continuous submission is not an option for U01 applications submitted in response to PAR-18-950, which has special application due dates. See NOT-OD-11-093 for more details.
Consideration after the application due date may be permissible in certain extenuating circumstances. There is a two week window of consideration after the due date, during which time NIH might consider accepting a late application. Request are considered on a case by case basis. Permission for late application submission is not granted in advance. Any reasons for late submission must be in relation to the individual(s) with the PD/PI role on the application. For multiple PD/PI (MPI) applications, the reasons may apply to any or all of the PDs/PIs. See NOT-OD-15-039 for more details.
In addition to any special requirements described in the FOA, there are a number of general requirements expected for all submissions regarding such things as page limits, biosketches, and inclusion of inappropriate information in an application. General compliance guidance may be found at NOT-OD-15-095. NIH has also published guidance regarding what kind of information should be included in the 1-page introduction for resubmission applications in NOT-OD-15-030 .